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Pharmaceutical Compliance Specialist

2 weeks ago


Newtown, Ireland Randstad Client Solutions Ireland Full time

About the Role:

We are looking for a highly motivated and organized Pharmaceutical Compliance Specialist to join our team at Randstad Client Solutions Ireland.

The successful candidate will be responsible for ensuring compliance with cGMP regulations through the review and approval of batch records for Cell Culture and Purification operations.

Key Responsibilities:

  1. Batch Record Review: Conduct thorough reviews of batch records to ensure accuracy, completeness, and compliance.
  2. QA Documentation Management: Manage QA documentation, including issue resolution and efficiency metrics.
  3. Change Management: Participate in change management initiatives, deviations, CAPA systems, and batch release reviews.
  4. Risk Management: Contribute to site risk management and maintenance of the Electronic Quality Management System.
  5. Vendor Management: Provide QA support to vendors, including assessments, audits, and qualifications.

**Required Skills and Qualifications:**

To be considered for this role, you will need:

  1. Bachelor's Degree: A Bachelor's degree in Science or a related field.
  2. Experience: At least 2 years of experience in a pharmaceutical environment.

What We Offer:

A competitive salary, pension, healthcare, and bonus scheme.